ASSISTANT MANAGER

Department Details

Role Summary

1. Updating the trackers and tracking of CAPA & Deviation 2. Review of CAPA projects, action implementation plan and effectiveness monitoring plan. 3. Review evidences and perform closure for CAPA and CAPAEM records 4. Data preparation for Review Board Meeting, Management Review Meeting and other meeting 5. as required. 6. Prepare trending report for CAPA, EVENT 7. Facilitate CAPA Review Board Meeting. 8. Preparation and review of Quality Assurance Standard Operating Procedure. 9. Participate in external OR internal audit, and coordinating external audit responses and compilation of supporting document for the evidence binder 10. Preparation and review of study protocols related to Quality Assurance department. 11. Impart training on Quality Assurance procedures. 12. To ensure closure of all QMS elements related. 13. Review of justification for delay (if any) in CAPA closure. 14. Ensure CAPA is appropriate as per root cause. 15. Verify the CAPA implementation and effectiveness for closeout. 16. Review and approval of CAPA plan and timelines. 17. Tracking of CAPA and CAPA effectiveness check plan with stakeholders to complete CAPA actions on time. 18.Define CAPA effectiveness check plan in trackwise and assigned to applicable stakeholder. 19. Archival of original records. 20. Initiation any QMS element related. 21. Review investigation report, impact assessment and closure of deviation report 22.Coordinating Investigation Review Board Meeting 23.Coordinating and summarize the plant shutdown activity 24. Review of event, incident and deviation. 25. Supporting other QMS activity depending upon the requirement. 26. Any other task given by reporting manager from time to time. 27. Assess the event and issue escalation notification to management and communicate to customer / partner as necessary

Key Responsibilities

1. Updating the trackers and tracking of CAPA & Deviation 2. Review of CAPA projects, action implementation plan and effectiveness monitoring plan. 3. Review evidences and perform closure for CAPA and CAPAEM records 4. Data preparation for Review Board Meeting, Management Review Meeting and other meeting 5. as required. 6. Prepare trending report for CAPA, EVENT 7. Facilitate CAPA Review Board Meeting. 8. Preparation and review of Quality Assurance Standard Operating Procedure. 9. Participate in external OR internal audit, and coordinating external audit responses and compilation of supporting document for the evidence binder 10. Preparation and review of study protocols related to Quality Assurance department. 11. Impart training on Quality Assurance procedures. 12. To ensure closure of all QMS elements related. 13. Review of justification for delay (if any) in CAPA closure. 14. Ensure CAPA is appropriate as per root cause. 15. Verify the CAPA implementation and effectiveness for closeout. 16. Review and approval of CAPA plan and timelines. 17. Tracking of CAPA and CAPA effectiveness check plan with stakeholders to complete CAPA actions on time. 18.Define CAPA effectiveness check plan in trackwise and assigned to applicable stakeholder. 19. Archival of original records. 20. Initiation any QMS element related. 21. Review investigation report, impact assessment and closure of deviation report 22.Coordinating Investigation Review Board Meeting 23.Coordinating and summarize the plant shutdown activity 24. Review of event, incident and deviation. 25. Supporting other QMS activity depending upon the requirement. 26. Any other task given by reporting manager from time to time. 27. Assess the event and issue escalation notification to management and communicate to customer / partner as necessary

Educational Qualifications

Required Education Qualification: B.Pharma
Required Experience: 4 - 6 years